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Analgesic efficacy of zoledronic acid and its effect on functional status of prostate cancer patients with metastasis



Rafael Gálvez1, Victoria Ribera2, José Ramón González-Escalada3, Alicia Souto4, María Luz Cánovas4, Andrés Castro4, Begoña Herrero5, María de los Ángeles Maqueda5, Matilde Castilforte6, José Javier Marco-Martínez7, Concepción Pérez8, Lorenza Vicente-Fatela9, Consuelo Nieto MD10, Maria José Orduña11, Anna Padrol12, Enrique Reig13, Joaquín Carballido14, José Manuel Cózar15

1Pain and Palliative Care Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain; 2Pain Unit, Hospital Vall d’Hebron, Barcelona, Spain; 3Pain Unit, Hospital Ramón y Cajal, Madrid, Spain; 4Pain Unit, Hospital Cristal Piñor, Ourense, Spain; 5Pain Unit, Hospital Virgen de la Macarena, Sevilla, Spain; 6Pain Unit, Fundación Jiménez Díaz, Madrid, Spain; 7Pain Unit, Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain; 8Pain Unit, Hospital La Princesa, Madrid, Spain; 9Pain Unit, Hospital Universitario 12 de Octubre, Madrid, Spain; 10Pain Unit, Fundación Alcorcón, Madrid, Spain; 11Pain Unit, Hospital Xeral-Calde, Lugo, Spain; 12Pain Unit, Hospital Joan XXIII, Tarragona, Spain; 13Pain Unit, Hospital Puerta del Hierro, Madrid, Spain; 14Urology Service, Hospital Puerta del Hierro, Madrid, Spain; 15Urology Service, Hospital Universitario Virgen de las Nieves, Granada, Spain

Objectives: A multi-centered observational study evaluated the efficacy of zoledronic acid for improving pain and mobility, and preventing skeletal-related events (SRE) (fracture, spinal compression, pain-relieving radiotherapy), in patients with prostate cancer and bone metastasis.

Materials and Methods: Males (n = 218) with prostate cancer and bone metastasis undergoing oncologic therapy received zoledronic acid (4 mg iv/month) for 6 months. Parameters evaluated were: 1) pain and movement after 2 consecutive doses; 2) quality of life; 3) SRE incidence and time-to-appearance. Medication tolerance and treatment satisfaction were assessed using a questionnaire.

Results: A total of 170 that matched all the inclusion criteria (78%) out of 218 were evaluable for efficacy. There was a measurable statistically significant reduction in pain at rest and on movement as well as an improvement in the quality of life compared with baseline. Best results were obtained with early treatment. Overall incidence of bone events was 11.2%. Of the 212 patients (97.2%) evaluable for safety, 16% suffered adverse events and 66% expressed satisfaction with the treatment

Discussion: Zoledronic acid is effective for reducing pain, improving mobility, and increasing the quality of life in patients with prostate cancer with bone metastasis. Its easy administration and good tolerability make zoledronic acid one of the principal therapeutic tools in the management of patients with pain associated with bone metastasis from prostate cancer.

Keywords: bone metastasis, pain, prostate cancer, zoledronic acid

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